FDA 510(k)

InterActive SMARTBase Abutments

Número K: K181359 · 2018-08-15

RequerenteImplant Direct Sybron Manufacturing, LLC

Data da decisão2018-08-15

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

InterActive SMARTBase Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2018-08-15 under 510(k) number K181359. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InterActive SMARTBase Abutments?

InterActive SMARTBase Abutments is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K181359.

When did InterActive SMARTBase Abutments receive FDA 510(k) clearance?

InterActive SMARTBase Abutments received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181359.

Who is the listed applicant for InterActive SMARTBase Abutments?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InterActive SMARTBase Abutments?

The FDA product code for InterActive SMARTBase Abutments is NHA.

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Fonte oficial

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